It is essential to remark that there are currently no FDA-approved or even supported tools for the therapy of the novel coronavirus (COVID-19), for which the World Health Organization (WHO) has reported as pandemic on Wednesday. Any tool or so-to-say- treatment being studied at this time is being administered in an innovative setting under controlled circumstances. Nevertheless, one of the fears of this virus is that there is no currently known method for it, and often it is the pharmacologist that people look to first for news about medicine extensions.
In February 2020, the WHO published a survey of the potential remedial contenders for the processing of COVID-19. The 36-page report outlines 76 regimens that have been proposed (as of February 17, 2020) for the treatment of the sufferers infected with the virus. Sixteen of the outstanding medications include an interferon-based stock. The rest cover a variety of antimicrobials, corticosteroids, convalescent plasma, and biologics.
Medication cases of several other products not listed in the WHO document have been posted to ClinicalTrials.gov, and the Chinese government has released several versions of guidelines for the prevention, diagnosis. The FDA approves therapy of the virus that includes specific medication recommendations. Some of the candidates for other indications. However, the majority of the remedies are not currently commercially accessible in the United States for healing use.
The agent that has received the most attention in the media is remadesivir, a nucleoside inhibitor, also known as GS-5734. The mono phosphoramidate prodrug has potent activity against individual families of RNA viruses. Formerly under development for Ebola, remdesivir combines into nascent viral RNA chains, and causes premature termination.
A recently published in vitro study showed that remdesivir had potent antiviral activity against COVID-19 in a human cell line. One case announced promising results from its use in a sufferer with COVID-19 in the US. Phase 2, multicenter, placebo-controlled, international study is currently recruiting adult sufferers. Four of the analysis sites are found within the United States. Sufferers randomized to remdesivir will get 200 mg IV on day 1, and then 100 mg IV once daily for the term of their hospitalization, up to 10 days total.
Two-phase three subjects expected to begin in March are set to conclude in May 2020. Both investigations have similar designs and will compare remdesivir 200 mg IV loading dose accompanied by 100 mg IV daily to standard of care treatment. Both studies have 5-day and 10-day therapy durations that are being assessed. Furthermore, the US Army Medical Research and Development Command is operating an expanded access program.
Different treatment that seems to have improved traction in evaluation for COVID-19 is hydroxychloroquine, or chloroquine. The heme polymerase inhibitor that is currently used to treat a type of conditions that include malaria, lupus, and rheumatoid arthritis is being assessed to determine if its use in COVID-19 leads to enhanced virological clearance and death number.
The same in vitro study that stated remdesivir’s antiviral activity also showed potent chloroquine activity versus COVID-19 in human cells. It appears to block viral infection by increasing the endosomal pH required for virus/cell fusion and interferes with the glycosylation of virus cellular receptors. The medication also has an immune-modulating activity, which is designed to improve its antiviral effect in vivo.
Chinese clinical research assessing five daily doses of 400 mg in adults who developed disease from the viral illness is scheduled to conclude in the latter half of 2020. The Shanghai Public Health Clinical Center sponsors the study, and it is unknown how long after the study conclusion, the information may be shared with other stakeholders.
A sizeable continuous research is comparing hydroxychloroquine clinical outcomes to capreomycin, lopinavir/ritonavir, and umifenovir, but the study is not anticipated to conclude before February 2021. The most recent Chinese guidelines on COVID-19 recommend chloroquine phosphate 500 mg twice a day for up to 10 days.
Given that hydroxychloroquine is already available in the US, comes in oral dosage forms, has a known safety profile, and is relatively inexpensive (compared to newer agents), it would not be as challenging to utilize this output as some of the other contenders, should the effects of any studies validate the findings of the in vitro study in a patient care setting.
Nevertheless, it is precisely because it is so readily available that it is necessary to note that until formal charges are made, any use of hydroxychloroquine for COVID-19 should only occur in the investigational perspective.
Among many other antivirals being reviewed, umifenovir is established in Russia and China for influenza treatment and opposition. It is a non-nucleoside broad-spectrum agent with immune-enhancing effects that possess antiviral activity against several other coronaviruses.
The current Chinese COVID-19 guidelines recommend a dose of 200 mg 3 times a day for up to 10 days. All of the studies of umifenovir are being carried in China, and there is no current indication of whether it may or may not be submitted to the FDA for approval if the outcomes of those studies are positive.
The WHO identifies baloxavir, a newer medication approved for influenza in the US as a possible candidate. The proposed regimen is 80 mg, given three times over seven days. No other details of a potential clinical trial for baloxavir are available, and the WHO is the only institution identifying it as a potential therapeutic candidate.
While infections are not overall, a new situation that we deal with, many patients in the US cannot recall a time when antimicrobials were unavailable. When novel pathogens emerge, the fear of not having a therapeutic method for combating the infection is excited.
The global pharmaceutical community has achieved at a quick pace to try to identify potentially useful and safe methods for COVID-19. There still needs to be substantially more data before specific agents and regimens can be recommended. Even the influx of clinical data that is appearing on a day-to-day basis is encouraging that COVID-19 will not be a virus without a known therapy for long.